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Bethesda North Marriott Hotel and Conference Center

2027年2月08日 (月) 午前 10:00 - 2027年2月10日 (水) 午後 12:45

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Data Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document and data management (RSIDM)!

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Early Bird Ends In

DAYS

HOURS

MINUTES

SECONDS

アジェンダ

10:00 AM — 5:05 PM

Forum Registration

11:30 AM — 12:30 PM

Networking Luncheon in the Exhibit Hall

12:30 PM — 1:00 PM

Welcoming Remarks and Presentation of the Excellence in Service Award

1:00 PM — 1:45 PM

Session 1 Opening Plenary: Turn Collaboration into Better Evidence: Use Digital Endpoints and Biomarkers to Improve Development Decisions

1:50 PM — 3:05 PM

Session 2: Stay Submission-Ready: The Latest on eCTD Standards and FDA Electronic Submission Portals

3:05 PM — 3:50 PM

Refreshment and Networking Break in the Exhibit Hall

3:50 PM — 5:00 PM

Session 3: FDA – Ask the Regulators

5:00 PM — 6:00 PM

Networking Reception in the Exhibit Hall

7:45 AM — 4:30 PM

Forum Registration

7:45 AM — 8:15 AM

Networking Breakfast in the Exhibit Hall

8:15 AM — 8:30 AM

Welcome to Day Two

8:30 AM — 10:00 AM

Session 4: Modernizing FDA-Industry Communication: How PDUFA VII Cloud Initiatives Can Improve Regulatory Collaboration

10:00 AM — 10:45 AM

Refreshment and Networking Break in the Exhibit Hall

10:45 AM — 12:00 PM

Session 5, Track 1: Structured Content, Smarter AI: Taming the Rising Cost of GenAI in Regulatory Operations

10:45 AM — 11:59 AM

Session 5, Track 2: Measure What Matters: Build the Visibility Needed to Improve Regulatory Performance

10:45 AM — 12:00 PM

Session 5, Track 3: Selecting, Scaling, Measuring, and Governing Regulatory Artificial Intelligence

10:45 AM — 12:00 PM

Session 5, Track 4: Accelerating Regulatory Transformation: Leadership, Governance, and Organizational Readiness for Digital-First Execution

12:00 PM — 1:15 PM

Networking Luncheon in the Exhibit Hall

1:11 PM — 2:30 PM

Session 6, Track 3: Operationalize AI Across the Clinical Data Lifecycle: Lessons from Biostatistics, Programming, and Data Management

1:15 PM — 2:30 PM

Session 6, Track 1: Future-Proof AI-Generated Regulatory Content: Building Inspection-Ready Evidence, Traceability, and Governance

1:15 PM — 2:30 PM

Session 6, Track 2: Building Bridges, Not Bottlenecks: Advancing Regulatory Agility Through Coordination, Dialogue, and Reliance

1:15 PM — 2:30 PM

Session 6, Track 4: Enabling Small & Mid-Sized Pharmaceutical Companies to Leverage Reliance Pathways, Data-Driven Decision Making, and AI

2:30 PM — 3:15 PM

Refreshment and Networking Break in the Exhibit Hall

3:15 PM — 4:45 PM

Session 7, Track 1: Beyond the PDF: How Digital Protocols, ICH M11, and USDM Can Accelerate Regulatory Review

3:15 PM — 4:45 PM

Session 7, Track 2: The Edit Room: Make Regulatory Process Change Stick

3:15 PM — 4:45 PM

Session 7, Track 3: Connect Regulatory Content from Source to Patient: Put FHIR and Structured Data Standards into Practice with Low-Cost Tools

3:15 PM — 4:45 PM

Session 7, Track 4: Beyond Documents: Designing the Future of Regulatory Data Collaboration
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